ORAL CANCER TREATMENT EDUCATION FRUQUINTINIB Name of your medication Generic name — Fruquintinib–(froo-KWIN-tih-nib) Brand name — Fruzaqla™ – (froo-ZAH-klah) Approved uses Fruquintinib is used to treat metastatic colorectal cancer. Dose and schedule Taking fruquintinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. o Your dose may vary, but the usual dose of fruquintinib is 5 milligrams (5 mg) to be taken by mouth once a day for 21 days followed by a 7 day break. o Fruquintinib can be taken with or without food, but at the same time each day. o Fruquintinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow fruquintinib, talk to your care provider or pharmacist for possible options. o If you miss a dose of fruquintinib only take the missed dose if it has been less than 12 hours since you were supposed to take it. Do not take two doses on the same day to make up for a missed dose. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions o Fruquintinib has many drug interactions. Please inform your care providers of all prescription medications, over-the counter medications, vitamins, and herbal products. o Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle fruquintinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. o Store fruquintinib at room temperature (68 to 77 F) in a dry location away from light. o Keep fruquintinib out of reach of children and pets. o Leave fruquintinib in the provided packaging until it is ready to be taken. o Whenever possible, you should give fruquintinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the fruquintinib to you, they also need to follow these steps. 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) Page 1 ORAL CANCER TREATMENT EDUCATION FRUQUINTINIB 3. Gently transfer the fruquintinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. o If a daily pill box or pill reminder will be used, contact your care team before using: • The person filling the box or reminder should wear gloves (gloves are not necessary if you are filling the box or reminder). • When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. o If you have any unused fruquintinib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of fruquintinib.. o If you are traveling, put your fruquintinib’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Page 2 ORAL CANCER TREATMENT EDUCATION FRUQUINTINIB Side Effects of Fruquintinib Below are common side effects that have been known to happen in about one-third or more of patients taking fruquintinib; these are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Increased blood pressure Kidney damage Fatigue Increased cholesterol levels Pain or discomfort on hands and/or feet Management Routinely take your blood pressure. Record your blood pressure in a journal/diary and report these to your physician. Contact your healthcare provider for high blood pressure or if symptoms such as the following occur: • Headache • Dizziness • Chest pain • Shortness of breath • Fluid retention, weight gain, or swelling Your care provider will monitor your kidney function by checking the amount of protein in your urine. You may be more tired than usual or have less energy. • Stay as active as possible, but know it is okay to rest as needed. • Try to do some activity every day. o Plan your activities, and do them at a time of day when you feel a bit more energetic. o Avoid operating heavy machinery if you feel too tired. Changes in cholesterol may occur and will be monitored by a simple blood test. You may not feel any symptoms if changes occur. Your care team will monitor for this. Hand-foot skin reaction (HFSR) appears on the palms of the hands and soles of the feet. It can appear as a rash, callus, or peeling skin, and the area has increased sensitivity to heat or a “pins and needles” sensation. Let your care provider know right away if you experience this side effect. To prevent HFSR, you can: • Soak your feet in a water bath with Epsom salt and gently pumice any callused skin. • Exfoliate and keep hands and feet moisturized. • Avoid tight-fitting shoes or socks. • Use cushioning (i.e., gloves) when performing activities that increase pressure on the palms of your hands. Continued on the next page Page 3 ORAL CANCER TREATMENT EDUCATION FRUQUINTINIB Possible Side Effect Changes in electrolytes and other laboratory values • High triglyceride levels • High cholesterol levels • High blood sugar • High alkaline phosphatase • High aspartate aminotransferase • High alanine aminotransferase • High bilirubin • Low sodium • Low albumin Management Changes in some lab values may occur and will be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you experience any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red or brown colored urine Voice changes or hoarseness Mouth irritations or sores These changes are not permanent and should go away during the time you are not taking the medication. Practice good mouth care. • Rinse your mouth frequently. • Brush your teeth with a soft toothbrush or cotton swab after meals. • Use a mild non-alcohol mouth rinse at least 4 times a day (after eating and at bedtime). One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm (not hot) water. • If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. Continued on the next page Page 4 ORAL CANCER TREATMENT EDUCATION FRUQUINTINIB Possible Side Effect Decreased platelet count and increased risk of bleeding Management Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. • Use caution to avoid bruises, cuts, or burns. • Blow your nose gently and do not pick your nose. • Brush your teeth gently with a soft toothbrush and maintain good oral hygiene. • When shaving use an electronic razor instead of razor blades. • Use a nail file instead of a nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: • A bloody nose that bleeds for more than 5 minutes despite pressure • A cut that continues to ooze despite pressure • Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, blood in your urine or stool, coughing up blood, or prolonged and uncontrollable bleeding. Serious side effects o You may have high blood pressure while taking fruquintinib. Take your blood pressure on a regular basis and let your care team know of any large increases in blood pressure. o You may be at a higher risk of bleeding while taking fruquintinib. Contact your care team if you notice frequent nose bleeds, blood in your stool, bleeding that occurs by itself without injury, or bleeding that will not stop after five minutes of pressure. o Fruquintinib may rarely cause a tear or hole in your intestine, called bowel perforation. Speak to your care team right away if you have a high fever, or nausea, vomiting, or severe stomach pain. o Fruquintinib may be harmful to your liver. Seek medical attention if you notice yellowing of the skin or whites of your eyes, dark or brown urine, bleeding, or bruising. o Fruquintinib may be harmful to your kidneys. Speak to your care team to know when you need to have blood tests to monitor your kidneys. Contact your care team if you notice swelling in your legs and feet or decreased amount of urination. o Fruquintinib can cause redness, pain, swelling, or blisters on the palms of your hands or soles of your feet. If you get this side effect, your doctor may change your dose or stop treatment for some time. o There is a low risk that you may develop a rare condition called posterior reversible leukoencephalopathy syndrome (PRES) while taking fruquintinib. Seek care immediately if you have severe headaches, seizures, confusion, or changes in vision. Page 5 ORAL CANCER TREATMENT EDUCATION FRUQUINTINIB o Fruquintinib can cause cuts or wounds to heal more slowly. Tell your care team if you have a wound that doesn’t heal properly. Also tell your care team if you have planned surgery or dental procedure, as fruquintinib should be stopped for at least 2 weeks before and after your surgery. Your doctor may restart fruquintinib after your surgical wound has healed. o Fruquintinib can increase your risk of having a blood clot. o Fruquintinib can increase your risk of infections. o Severe allergic reactions are a rare but serious side effect of fruquintinib. Immediately seek medical attention if you notice difficulty breathing, swelling of the mouth or tongue, or a serious rash. o Fruquintinib can cause serious birth defects. Do not take fruquintinib if you are pregnant or think you might be pregnant. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: Handling body fluids and waste Because fruquintinib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take fruquintinib, it is important to know the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. o Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. o Toilet and septic systems: • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low-flow toilet, close the lid and flush twice to ensure that all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. o If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. o If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. o Wash any skin that has been exposed to body waste or fruquintinib with soap and water. o Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. o Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception o You should not become pregnant or get a partner pregnant while taking fruquintinib. All people of childbearing age and potential should use effective contraception during therapy and for a minimum of 2 weeks after the last dose of fruquintinib. o Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. o Do not breastfeed while taking fruquintinib and for 2 weeks after the last dose of fruquintinib. Page 6 ORAL CANCER TREATMENT EDUCATION FRUQUINTINIB o Please inform your care provider if you become pregnant. o It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral therapy and you are encouraged to ask your care team for assistance. Obtaining medication o Talk with your care provider about the process for obtaining your fruquintinib. Additional resources Product website: https://www.fruzaqla.com Product prescribing information: https://www.fruzaqla.com/sites/default/files/resources/fruzaqla-prescribing -information.pdf Product resources: https://www.fruzaqla.com/sites/default/files/resources/fruzaqla-patient-information.pdf Additional instructions Updated – January 12, 2024 Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Cancer Treatment Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy-to-understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2024 by Hematology/Oncology Pharmacy Association. All rights reserved. Page 7